Bronchial Challenge Test of Magnesium-treated Asthmatics

September 3, 2013 updated by: University of Aarhus

Metacholine-provocation of Mablet-treated Asthmatics

The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease.

The aim of this part of the project is to study the effect of a daily magnesium supplement on the grade of bronchial hyperreactivity in asthmatics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Research Dept. of Respiratory Medicine, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Asthma with annual symptoms, bronchial hyperreactivity and positive metacholine-test (PD20<1000 microgram

Exclusion Criteria:

  • Se-Mg > 2,00 mmol/L, smoking cessation less than 1 year prior to study start, major changes in eating habits within three months prior to study start and during the study period of approx. one year, various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Dietary supplement: Placebo
3 placebo-tablets daily for 12 weeks
NO_INTERVENTION: Washout
ACTIVE_COMPARATOR: Mablet
Dietary supplement: Magnesium supplement (magnesium hydroxide/ -oxide)
3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS
Other Names:
  • Mablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PD20 for metacholine
Time Frame: Two years
Bronchial hyperreactivity is expressed by the dose of inhaled metacholine necessary to achieve a decline of 20 % in FEV1 (Bronchial challenge test).
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impulse Oscillometry for measurement of pulmonary impedance
Time Frame: Two years
A characteristic feature of Impulse Oscillometry is that pulmonary impedance is not derived from the respiratory signals but from the pressure-flow relationship of artificial impulse-shaped test signals which are produced by an external generator. The advantage of artificial test signals is the incomparably higher frequency contents with a relatively high consistency as far as frequency range and amplitude are concerned, so that a thorough differentiation of pulmonary function is possible.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Gunnar Kjems APS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

April 27, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (ESTIMATE)

May 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 4, 2013

Last Update Submitted That Met QC Criteria

September 3, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9727d

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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